Device for assaying analytes in bodily fluids

ABSTRACT

A device for determining the presence and/or quantity of one or more analytes in a sample of human body fluid has a container for receiving a sample of body fluid, with an interior that is delimited by a base and by a circumferential surface. It further comprises at least one test strip and a holding element for receiving and holding the one or more test strips. The holding element is designed such that it has a shape corresponding and adapted to the peripheral circumferential surface of the container. The device further comprises an elongate sampling element having an absorbent sampler that takes up the sample of body fluid and by means of which the sample of body fluid is transferred into the container. The sampling element can include an indicator strip for determining whether the amount of liquid sample sufficient for carrying out an assay.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/211,208, filed Aug. 16, 2011, which is a continuation of co-pendingInternational Patent Application PCT/EP 2010/000948 filed on Feb. 16,2010, and designating the US, which international Patent Application hasbeen published in German language as WO 2010/091897, and claims priorityfrom German Patent Application DE 10 2009 010 563.8 filed on Feb. 16,2009. The entire contents of these priority applications areincorporated herein by this reference.

BACKGROUND OF THE INVENTION

The present invention relates to a device for determining the presenceand/or quantity of one or more analytes in a sample of human body fluid,comprising a container for receiving a sample of body fluid, and furthercomprising at least one test strip with an absorbent section and withreagents for determining the presence and/or quantity of one or moreanalytes in the sample.

More specifically, the present invention concerns a device forcollecting and testing a liquid sample, as is used in particular intests for a drug or for multiple drugs. For this purpose, the presenceand/or quantity of one or more analytes, in particular drugs of abuse,is determined from a sample of a body fluid, for example saliva orurine. The result can be determined visually by means of test strips.

Various analytical devices with which analytes in a sample can bedetected are known from, for example, EP 0 225 054, EP 0 183 442, EP 0186 799, EP 0 299 359 and WO 89/06799. All of these devices use teststrips impregnated with reagents in specific binding assays in which aliquid sample is applied to an end of the test strip and migrates acrossor through the test strip. The test strip can in these cases be providedin a cover. If the analyte that is to be detected is present in asample, it can be detected by a binding reagent immobilized in adetection zone, for example by a sandwich assay or a competitive assay.

Moreover, test cards are known that comprise test strips with whichamphetamines and drugs such as ecstasy, cocaine, crack or opiates andcannabis are intended to be detected in parallel.

Suitable detection methods are, for example, immunoassays, which arehighly sensitive detection methods based on the specificity ofimmunological reactions. The substances are detected using an easilydetectable and measurable indicator substance, for example radioactiveisotopes, enzymes, dyes, for example gold sols, and fluorescence dyes.

The tests presently on the market are solid-phase tests. A markedantigen or a marked antibody, which is specific for the substance to bedetected, is located in a first zone which first comes into contact withthe liquid sample. If the sample contains an analyte that is recognizedby the specific antibodies or antigens, these bind to the analyte andmigrate with the latter through the solid carrier as far as a secondzone, where a further reagent is bound which also specificallyrecognizes either the analyte or the antibody/antigen. The binding ofthe analyte-antibody/analyte-antigen reaction product in the second zonemeans that the analyte can be detected, for example, by an accumulationof the markers, or by a chemical reaction triggered by the binding.

Solid-phase immunoassays in the competitive or sandwich technique areknown to persons skilled in the art and for this reason do not have tobe explained in detail here.

Moreover, DE 200 21 659 U1 discloses a device in which samples of bodyfluid, in particular urine, are tested for a plurality of drugs of abusesimultaneously. Test strips are arranged on a test card, each stripbeing sensitive to a specific drug of abuse and having a visible limitvalue in order to indicate the presence or absence of a specific drug.The container used has, at its upper end, a closure lid which has a slotof such a size that a test card with test strips can be fitted therein.The test card can be inserted through the slot in such a way that oneend is immersed in the urine sample to a predetermined depth, thevisible result from each test strip being able to be seen by virtue ofthe transparency of the wall of the container without removing the testcard from the container. When samples test “positive”, it is necessaryfor the slotted lid to be replaced by a second, unslotted lid and toremove the test card from the container, in order then to be able tosend the closed container to a certified laboratory.

Another disadvantage of the tests known from the prior art is that, foran initial detection of the drugs, sufficient quantities, i.e.,relatively large quantities, of body fluids are needed in order to allowthe tests to be carried out. Particularly for detecting drugs in saliva,the consistency and availability of the latter mean that quite largequantities are needed, which makes rapid drug detection, for example ofthe kind that is intended to be performed in direct on-site tests,difficult to achieve when using saliva. For this reason, most of thepresently available tests are based on the use of urine samples.

SUMMARY OF THE INVENTION

Against this background, it is an object of the invention to permit animproved and more simply designed device for the analysis of liquidsamples, which does not require any additional aids for preparing thesample.

According to one aspect of the invention, there is provided a device fordetermining the presence and/or quantity of one or more analytes in asample of human body fluid, comprising a container for receiving asample of body fluid, with an interior that is delimited by a base andby a circumferential surface, further comprising at least one test stripwith an absorbent section and with reagents for determining the presenceand/or quantity of one or more analytes in the sample of body fluid, andcomprising a holding element for receiving and holding the one or moretest strips, said holding element having a shape corresponding andadapted to the peripheral circumferential surface of the container; thedevice according to the invention further comprises an elongate samplingelement which, at one of its ends, has an absorbent sampler that takesup the sample of body fluid, which sampling element can be inserted intothe container, via its end comprising the sampler, in order to transferthe sample of body fluid into the container, and in that the base of thecontainer has a central elevation or protrusion via which the sample ofbody fluid can be conveyed from the sampler, by compression thereof onthe elevation, to the at least one test strip.

By means of the elongate sampling element and the absorbent samplerprovided thereon, it is possible, by interaction with the elevationprovided on the base of the container, for the sample of body fluid, forexample saliva, which has been taken up into the absorbent sampler, tobe squeezed out in the container and to be conveyed to the absorbentsections of the test strips present in the container; almost the wholesample that has been taken up is utilized in this process, with theresult that only relatively small quantities of the sample are needed.

The elongate sampling element, which comprises a sampler at one of itsends, can be used to collect a sample of saliva, for example, from aperson's mouth or throat, i.e., the nature of the absorbent sampler issuch that the saliva is sucked up by the sampler. The material fromwhich the sampler is made can be any absorbent material, preferably amaterial with cotton-like or sponge-like properties, which, whensqueezed out or pressed out, allows the sample contained therein toeasily emerge from the material and additionally does not alter thecomposition of the saliva. It is within the competence of a personskilled in the art to provide a material suitable for these purposes.The sampling element comprising the sampler, fully soaked with salivafor example, is then placed into the container, where it is pressed ontothe elevation provided centrally on the base of the container, and theliquid sample, for example saliva, contained in the sampler is thussqueezed out. The sample then flows across the elevation to the sideedge at the base of the container, where the absorbent section of the atleast one test strip is located and takes up the sample by capillaryforces. The sample then migrates across or up the test strip, as aresult of which any analytes present in the sample can be detected inthe manner described above.

With the device according to the invention, an easy-to-use testappliance is thus made available which is also suitable for testingsamples of saliva and with which the analytes that are to be detected ina sample can be detected rapidly. The centrally arranged elevation alsoensures that the sample contained in the sampler is squeezed outuniformly and is guided uniformly to the peripheral inner edge of thecontainer. The absorbent sections of the one or more test strips presentthere are thus supplied uniformly with the sample.

In the present context, an “elongate” sampling element signifies anystick- or rod-shaped element that is suitable for being gripped at itsone end by the person being tested or by a third party, such that theother end can be inserted into the mouth/throat in order to collect asample of saliva, for example. The sampling element according to theinvention therefore has an end at which the sampler is provided and agripping end, as well as an elongate, stick- or rod-shaped section lyingin between. It will be appreciated, however, that the sample is notlimited to a sample of saliva, since the sampling element can also bedipped into another receptacle containing the liquid sample, as a resultof which the sampler can likewise be fully impregnated with the sample.The sample that has been taken up in this way is then guided into thecontainer, as has been described above, and the test for determining thepresence or quantity of an analyte is started by squeezing the sampleout from the sampler and bringing the test strips into contact with thesample.

In a preferred refinement, the sampling element and/or the sampler areprovided with at least one means that indicates that, and whethersufficient, liquid sample, in particular saliva, has been taken up.

In another preferred refinement, the at least one means is an indicatorstrip of an absorbent material that is present in the sampling elementand has at least one zone which lies away from the sampler and in whichit is indicated when sufficient liquid sample, in particular saliva, ispresent by the colour of the material changing. The absorbent materialis in this case preferably a material comprising cellulose and makes itpossible for the liquid sample to be able to migrate through or acrossthe indicator strip and arrive in the zone in which the change in colouris observed. In this case, the change in colour of the material maycomprise a darkening of its colour that is brought about by the liquidsample taken up by and migrating across the material.

In another preferred refinement, the change in colour may take place bya reaction of the material with the liquid sample in the manner of a pHindicator paper, according to which the material changes its colour, ortakes on a colour if the material was previously colourless, at least inthe zone. It will be appreciated that the indicator strip eitherundergoes a change in colour as a whole when the liquid sample migratesacross or through the indicator strip, or else only in the zone on thebasis of which the presence of a sufficient amount of liquid sample isindicated. In the case of the latter embodiment, the zone iscorrespondingly impregnated, or has a different composition than therest of the material of the indicator strip. Furthermore, it may beprovided that only the zone can be observed via a window, while the restof the indicator strip is covered with an opaque material.

In another preferred refinement, at a certain distance from the sampleron the rod-shaped section of the sampling element, the sampling elementmay be provided with a marking, for example in the form of a line or anotch, which is intended to serve as an indication as to how far thefront of the liquid sample must travel across the indicator strippresent in the sampling element to ensure the presence of a sufficientamount of liquid sample in the sampler. It will be appreciated that inthe case of this embodiment the indicator strip as a whole can be seen.

The indicator strip by means of which it is indicated when sufficientliquid sample is present may, for example, be arranged ina—cross-sectionally—U-shaped recess in the rod-shaped section of thesampling element, and protrude with one of its ends into the sampler,which comprises a sponge-like material, or be received therein. Thisallows the liquid sample that is received by the sampler to reach theindicator strip and migrate across the indicator strip by capillaryforces.

In a preferred refinement of the device according to the invention, itis also preferable if the elevation is a hemispherical elevation withits highest point located centrally in the base of the container.

This measure has the advantage that the sample contained in the samplercan be easily squeezed out on the hemispherical elevation, after whichthe sample flows down the elevation, on account of the hemisphericalshape of the elevation, and towards the edge of the base or to the sitewhere the base merges into the circumferential surface. Here, the sampleis taken up by the absorbent section of the at least one test strip, andthe detection of the analyte on the test strip proceeds.

In the device according to the invention, the space between the outerperipheral edge of the hemispherical elevation and the outer peripheraledge of the base, i.e., where the base meets the circumferentialsurface, is dimensioned such that the absorbent section of the teststrip fits into this space. Moreover, the surface within this space canslope downwards to the edge of the base, so as to further promote theflow of the sample in the direction from the elevation down to the edgeof the base.

In another refinement of the invention, the elevation comprisesridge-shaped elements that extend centrally from the elevation towardsthe base in order to convey the sample to the peripheral edge of thebase of the container.

In this context, “ridge-shaped” is intended to signify any element thatassists in the function of conveying the sample down from the elevation,in particular narrow, elongate elements fitted along the outer surfaceof the elevation, in the manner of ribs.

This measure has the advantage that the liquid sample is distributed inan improved and targeted manner about the peripheral edge of the basesuch that, if several test strips are arranged with their absorbentsection at the peripheral edge, all the test strips are also suppliedwith a defined amount of sample.

In another refinement of the device according to the invention, the baseof the container has a depression in the area of and extending aroundthe circumferential surface, for the purpose of receiving the sampleflowing down from the elevation.

This measure has the advantage that the saliva that flows down acrossthe elevation, after the sampler has been squeezed out on the elevation,is collected and concentrated in a kind of groove or peripheral channel,such that the one or more test strips, which are arranged with theirabsorbent section in this depression or groove or channel, are suppliedeven more reliably with a sufficient amount of the liquid sample.

In another refinement, the at least one test strip, with its absorbentsection taking up the sample, is adapted to the shape of the depression.

In this case, provision can be made, for example, that the absorbentsection of the one or more test strips is bevelled with a wedge shapeand is provided with its pointed end protruding into the depression.This measure has the advantage that the liquid sample can be transportedin an even more concentrated form to the absorbent section, therebyensuring a more reliable test procedure.

In another refinement of the device according to the invention, thesampling element, at its end remote from the end with the sampler, has aclosure means for closing the container after the sampling element hasbeen introduced into the container.

The closure ensures that the test can proceed without the sample beingdisturbed or affected. Moreover, this also ensures the safe transport ofthe device, for example to prepare the device for introduction into areading appliance or scanner without any danger of the sample escapingfrom the container. The closure is advantageously at the same time thegrip part of the sampling element, such that the latter can be securelyheld and safely handled via the closure. In this case, the sample ofsaliva is thus collected by inserting the other end of the samplingelement, i.e., the end comprising the sampler, into the mouth or throatand by taking up/absorbing the saliva located therein into the sampler,while the sampling element is handled via the other end with theclosure, which at the same time can be used as a grip, specificallyeither by the person who is to be tested or by another person.

In a refinement of the invention, the closure means is a press-fit,clip-on, rotary or bayonet-fit closure or a sealing ring which interactsin each case with the container and/or the holding element and/or aninsertion element. It will be appreciated that the closure means can beconstructed in one or more pieces, depending on the nature of theclosure. It will also be appreciated that the closure means of thesampling element can interact with means provided on the correspondingparts of the container, in order to firmly close the container. Thus,the upper end of the container, i.e., the end that is intended to beclosed, can have a mating thread, for example, in cases where theclosure means of the sampling element has a threaded section.

In this case, the end of the sampling element may alternatively oradditionally be provided with closure means which are inserted into thecontainer, for example in the position in which the sampler is fixed onthe rod-shaped section. These closure or fixing means on the samplingelement can then interact with corresponding means in the holdingelement or in the container and/or with an insertion element for fixingthe sampling element.

Moreover, it will be appreciated that, in addition to the closure means,a grip element can also be provided with which, for example in the caseof a rotary closure, the sampling element can be taken hold of andscrewed into the container.

In a refinement of the invention, the closure means is provided withmeans which, after the sampling element has been introduced into thecontainer, block the removal of the sampling element from the container.In this case, it is particularly preferable if the means in question isa locking means that prevents the sampling element from being screwedout or pulled out after it has been introduced into the container.

Thus, by means of the closure piece, and by means of the container beingclosed by the closure piece, that is to say after introduction of thesample, for example the sample of saliva, it is ensured that the contentof the container is not altered, in particular that the sample is notsubsequently altered or adulterated. Moreover, this affords thepossibility that the sample located in the container can also be usedfor further tests (“B-sample”). This means that the competent authority,or the person carrying out the test, can be assured that the samplepresent in the container is unadulterated, that is to say is in thestate in which it was removed from the test subject. It can then besafely used for further tests.

In a preferred embodiment, the sampling element can therefore beconstructed such that a closure section, for example a rotary closuresection, is connected to what is by comparison a thinner, elongate,rod-shaped section, which in turn is connected by its other end to theabsorbent sampler. The length of the sampling element is such that, whenthe element is introduced into the container and the container isclosed, the absorbent sampler is either in a compressed state or in anuncompressed state, but the container as a whole is closed. In thecompressed state, the user has to apply pressure to the sampler in orderto close the container; in the uncompressed state, the sampler has to befirst squeezed out in order to carry out the test, after which thecontainer can then be closed without pressure being applied to thesampler.

In this connection and in a preferred refinement, the closure means hasa pierceable, self-sealing element which, after it has been pierced,permits access to the interior of the container even after the closuremeans has been fitted onto the container.

This measure has the advantage that, when it is necessary to carry outfurther tests using the originally collected sample, it is possible tohave simple and quick access to this original sample, specifically by asyringe or cannula or a similarly shaped and tapered sampling meansbeing passed through the film-like element such that the latter ispierced, and the syringe/cannula/sampling means being used to removesome of the unused sample for further tests.

According to one embodiment of the device according to the invention, itis preferable if the container is a cylindrical container with acircular base.

In another embodiment, it is preferable if the container is a cuboidcontainer with a rectangular base. This embodiment has the advantagethat it can, for example, be read out by means of a scanner, since theplanar sides of the container make uniform reading possible.

Irrespective of the specific shape of the base and the circumferentialsurface, a shape of the holding element that is adapted “to the shape ofthe circumferential surface” should be understood as meaning that theshape of the holding element or the holding element is adaptedperipherally to the shape of the circumferential surface forming theinner side of the container such that that it covers the entireperipheral inner circumference of the circumferential surface. Thismeans that, if the circumferential surface is designed asa—hollow—cylinder, in particular a circular or angular cylinder, theholding element is also designed as cylindrical, in particularcircular-cylindrical or angular-cylindrical. It will be appreciated thatthe holding element does not necessarily also cover the entire height ofthe cylinder. Accordingly, the holding element is designed as a hollowcylinder which is adapted to the inner cylindrical shape of thecircumferential surface.

It is also preferable if the holding element bears at least partially onthe inner face of the circumferential surface of the container. Thebearing of the holding element on the inner face of the circumferentialsurface thus prevents direct contact between the liquid sample and thatpart of the test strip that contains the reagents. In this way, onlythat part of the test strip not containing any reagents comes intodirect contact with the liquid sample. Some of the sample is then drawnby capillary forces in the longitudinal direction of the test strips andinto the area of the reagents. This prevents contamination of the liquidsample, which is why the sample can be sent to a laboratory for furthertests without taking out the test strips.

It is also preferable if the holding element is at least partiallyspaced apart from the inner face of the circumferential surface of thecontainer. The spacing apart of the holding element is advantageous,since this facilitates contact between the sample to be tested and thetest strips.

According to another embodiment, the holding element is shaped withpretensioning and clamped into the container. The pretensioning of theholding element permits a good clamp fit within the container andprevents slipping of the holding element and of the test strips arrangedtherein. This is in turn important for preventing contamination of thesample by the reagents arranged on the test strips.

In another preferred embodiment, the holding element is at leastpartially bonded to the container, in particular to the inner face ofthe circumferential surface and/or of the base. Like the abovementionedclamp fit, the bonding of the holding element to the container canprevent slipping of the holding element and thus prevent contaminationof the sample.

It will be appreciated that this bonding can also be used in combinationwith the clamp fit, thus additionally improving the connection betweenholding element and container.

As an alternative to this, it is possible for the holding element to befitted through a guide means arranged on the base of the container. Aguide means on the base of the container has the advantage that theholding element can be inserted more easily and thus more quickly intothe container during production.

Moreover, in a preferred refinement, the holding element has recesses inwhich the test strips are respectively arranged. The recesses allow thetest strips to be fitted in place and prevent slipping of the teststrips inside the holding element, that is to say in the longitudinaldirection of the test strips.

It is also preferable in this case if the recesses are separated bywebs, which bear at least partially on the inner face of thecircumferential surface of the container. The separation by websarranged between the individual test strips prevents contact between thereagents of the various test strips. In addition, the webs can preventthe liquid sample from getting into that area of the test strips wherethe reagents are arranged, such that the liquid sample can reach onlythe lower free end of the test strips where there are no reagentspresent. This therefore prevents contamination of the sample itself andensures that the individual test strips and their reagents do notinfluence one another.

In the aforementioned device, it is also preferable if at least part ofthe circumferential surface of the container has a transparent area inthe region of the test strips. It is thus possible to ensure that thereis a direct optimal view of the test strips and that the result can beread off without removing the holding unit.

In another embodiment, it is preferable if the holding element has adarker colour compared to the test strips.

This measure has the advantage of making it much easier to read off thetest result on the test strip, since the contrast between the thenbrighter test strip and the holding element is greater than if theholding element is the same colour as or brighter than the at least onetest strip.

The liquid sample to be tested can be any liquid sample of a body fluidfrom a human- or mammal in general—preferably saliva.

It is also preferable if the transparent area is concealed by an atleast partially detachable covering element, in particular by a filmthat cannot be seen through. The covering element affords the advantageof preventing the test results from being read off by the subject or byother unauthorized persons.

In another preferred embodiment, the size of the covering element ischosen such that the area of the circumferential surface adjacent to thebase is not concealed by the covering element. Through the uncoveredarea remaining at the lower end of the circumferential surface, theperson carrying out the test can identify directly whether the liquidsample to be tested is present in the container in a sufficiently largequantity to permit contact with the test strips.

According to another preferred embodiment, a cover element, inparticular a protective film, covers the test strips arranged in therecesses of the holding element. The covering of the test strips,particularly in the area containing the reagents, is advantageous sinceit prevents direct contact between the liquid sample and the reagentspresent on the test strips. The liquid sample thus comes into contactwith the test strips only at the lower part of the test strips, wherethere are no reagents present. Some of the liquid sample is then drawnby capillary forces into the area of the reagents. This in turn preventscontamination of the sample.

The device according to the invention can have between 1 and 12 teststrips, in particular, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 or 12 teststrips, which can each be used after insertion into the holding element.It is particularly preferable for the device to have at least six teststrips.

In a further embodiment it is preferred if an insertion element by meansof which the sampling element can be inserted into the container isadditionally provided. The insertion element preferably has a hollow,substantially cylindrical shape, with an upper end, opposite from thebase of the container, and a lower opening, facing the base. Thesampling element may be inserted into this insertion element via theupper end thereof, and reaches through the lower opening into thecontainer, and can as a result be squeezed out on the elevation providedon the base. It will be appreciated that the insertion element is eitheralready inserted in the container—and as a result also in the holdingelement present therein—and only then is the sampling element inserted,or on the other hand the sampling element may have already been broughttogether with the insertion element before insertion into the container,and this assembled arrangement is inserted into the container.

The insertion element offers the advantage that additional fixing of thesampling element is made possible. In a preferred embodiment, theinsertion element may also have at the upper end two lateral flanges,which limit insertion of the insertion element by the flanges lying onthe upper edge of the container.

In a further embodiment it is preferred if the base of the container hasmeans by which the sample of body fluid can be conveyed from theelevation to the side edges of the base, in particular the long sideedges in the case of a rectangular base. This ensures that the sample ofbody fluid is conveyed from the elevation to the region into which theabsorbent sections of the test strips protrude, and so starting of thetest is ensured after the squeezing out. In a preferred embodiment,these means are elevations which are provided at a distance from theelevation on which the sampler is squeezed out and in each case adjacentto the short side edges of the base.

Irrespective of the particular embodiment, the device according to theinvention can be used for any type of test for a drug or for multipledrugs. The sample of liquid can be tested at one and the same time forseveral drugs of abuse, including in particular amphetamines,barbiturates, benzodiazepines, cocaine, marihuana, methadone,methamphetamine, methylenedioxy-methamphetamine, morphine, opiates,oxycodone, phencyclidine, propoxyphene, tricyclic antidepressants,buprenorphine, cotinine, EDDP(2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine) and fentanyl.

The analytes, in particular drugs, are preferably detected using animmunoassay based on the principle of competitive binding. For thispurpose, the test strip contains, for example on a test line, amembrane, for example a nitrocellulose membrane, coated with analyte (inparticular drug)-protein conjugates (for example pure bovine serumalbumin) and, on a control line, a polyclonal antibody (goat) againstgold protein conjugate and a colour field with gold particles that arecoated with specific monoclonal antibodies for the drugs to be detectedand are immobilized in the test field. If drugs are present in theliquid sample, these compete with their conjugates for binding sites ontheir specific antibody. During the test, the sample, for example, urineor saliva, migrates “upwards” by capillary forces, i.e., from thesample-receiving end of the test strip to the upper end of the teststrip. The drug-protein conjugates on the test strip go into solutionand migrate with the sample to the test area of the corresponding drugdetection strip. Drugs that are contained in concentrations below thedetection limit in the liquid sample, particularly saliva, do notsaturate the binding sites of their specific antibodies immobilized inthe test field, such that the antibodies in this case react with theconjugates, as a result of which a coloured line becomes visible. If theconcentration of the drugs in the urine or the liquid sample is higher,the drug molecules drive the conjugates from the urine or occupy all theantibody binding sites, as a result of which no coloured line is formed.

To check whether the test has been performed correctly, i.e., whetherthe test strips are working properly, for example, or whether asufficient amount of the sample has been taken up by the test strips,the test strips can have a control area in which a coloured line appearseach time the test is carried out, independently of any drugs possiblypresent in the urine or the liquid sample.

In a preferred embodiment, the following detection limits are providedfor certain drugs: amphetamine: ca. 50 ng/ml and upwards; cocaine: 20ng/ml and upwards; marihuana (tetrahydrocannabinol): ca. 20 ng/ml andupwards; methamphetamine 50 ng/ml and upwards;methylenedioxymethamphetamine: ca. 50 ng/ml and upwards; opiates: 40ng/ml and upwards; phencyclidine: ca. 10 ng/ml and upwards.

The test strips can be designed in one or more pieces. In the presentcontext, “one or more pieces” means that the test strip can be formed inone section or from several interconnected, for example overlapping,parts which can be made of different or identical materials withdifferent or identical dimensions.

It will also be appreciated that one or more analytes, preferably twoanalytes, can be detected on one or more test strips, that in additioncontrol zones can also be provided for confirming that the test has beencarried out completely and correctly, and that the strips can bepreceded by samplers that serve, for example, to take up and forward thesample. All of these features are known to persons skilled in the artand represent routine technical features belonging to the generaltechnical knowledge in this field. In this respect, reference is alsomade explicitly to the disclosures of the aforementioned documents EP 0225 054, EP 0 183 442, EP 0 186 799, EP 0 299 359 and WO 89/06799, whichlist a number of analytes to be detected and also a number of samples.

According to a further embodiment, it is also preferable if the teststrips include an alcohol test. The alcohol test makes it possible notonly to test the sample for illegal drugs of abuse or other analytes,but also to combine this with detection of the alcohol content of thesample. In police checks in particular, this embodiment can thus providea quick and simple indication that the subject is unfit to drive.

In a preferred embodiment, an alcohol content of at least ca. 0.04% isdetected. It is preferable if the detection takes place by a reaction ofthe enzymes alcohol oxidase, peroxidase and an enzyme substrate, forexample tetramethylbenzidine, in the presence of ethanol.

With the test strip for detection of alcohol, it is advantageously onlythe actual presence of alcohol that is detected. However, other measurescan be taken in order also to determine the amount of alcohol present inthe sample, for example a reaction providing a colour intensity whichdiffers in intensity, in particular with an increasing alcohol content,and which can be read off on the basis of a scale that is also supplied.

Moreover, in another embodiment, it is preferable if the devicecomprises at least one test strip for detecting adulteration of thesample.

It is particularly preferable in this case if the test strips for theadulteration tests include a colour reaction, which is then comparedwith colour fields on a colour scale. These colour scales can besupplied together with the device, such that the user himself candirectly test for/detect adulteration. It is particularly preferable ifthe colour reaction is classed as “normal” (unadulterated sample) and“abnormal” (adulterated sample).

It is also preferable that the container is a cylindrical container witha circular base and that the holding element has a curved shape adaptedto the circular cross section of the circumferential surface. Thecontainer is thus a round beaker, thus facilitating the insertion of theholding element and, later, the reading off of the test results. Thecylindrical container can preferably have a diameter of ca. 1 cm to ca.15 cm, preferably of between ca. 1 cm and 5 cm.

It will be appreciated that the aforementioned features and those stillto be explained below can be used not only in the respectively citedcombination but also in other combinations or singly, without departingfrom the scope of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments of the invention are explained in more detail inthe following description and are illustrated in the drawing, in which:

FIG. 1 shows a schematic view of the individual elements of anembodiment of the device according to the invention, in the unassembledstate, which device is used to test samples of body fluids.

FIG. 2a shows a schematic view of the elements from FIG. 1 in theassembled state, without a covering.

FIG. 2b shows a view as in FIG. 2a , with partial covering of the teststrips and containers.

FIG. 3 shows an enlarged perspective view of an embodiment of the baseof the container of the embodiment shown in FIGS. 1 and 2.

FIG. 4 shows a detail of the lower section of the container comprisingthe base of the embodiment shown in FIG. 3, with the sampling elementinserted into the container, and with the sampler in the compressedstate on the elevation.

FIG. 5 shows a detail of the upper section, comprising the grip and theclosure means, in one embodiment of the sampling element.

FIG. 6 shows a detail of an embodiment of the closure means, inengagement with means that are correspondingly provided in the containerand are used to close the device.

FIG. 7 shows a detailed plan view of the sampling element of anembodiment of the device according to the invention with means forindicating a sufficient amount of liquid sample in the sampler.

FIG. 8 shows a further embodiment of a sampling element, in longitudinalsection (A) and in an exploded representation (B).

FIG. 9 shows a further embodiment of the device according to theinvention, the partially assembled form being shown in (A); the holdingelement removed from the container being shown in (B); the samplingelement being shown in (C) and an insertion element for the samplingelement being shown in (D).

FIG. 10 shows a cross section through the assembled embodiment shown inFIG. 9.

FIG. 11 shows a plan view of the base of the container of the embodimentshown in FIGS. 9 and 10.

DESCRIPTION OF PREFERRED EMBODIMENTS

An embodiment of a device 10 according to the invention for testingsamples of liquid is shown in FIG. 1, where the individual elements ofthe device 10 are depicted, and the device 10 as a whole is in theunassembled state.

The device 10 comprises a container 12, and a holding element 13 whichis to be arranged in the container 12 and which holds one or, as isshown in FIG. 1, several test strips 18. The test strips 18 haveabsorbent sections 19 via which the liquid sample is taken up and thetest is thereby started on the test strip 18.

In the embodiment shown in FIG. 1, the container 12 is cylindrical witha circular base 15 and with a roundly curved circumferential surface 16.The container 12 also comprises, at its upper end, a thread 17 which, byengagement with corresponding means, serves to close the container 12.

The holding element 13 has lengthwise axial recesses 14 a, which areseparated from one another by webs 14 b lying between the recesses 14 a.The recesses 14 a and the webs 14 b are delimited at the top by a freesurface of the holding element 13. However, the recesses 14 a of theholding element 13 continue as far as the bottom end thereof. In FIG. 1,test strips 18 are inserted in the recesses 14 a of the holding element13. In this embodiment, the test strips 18 are inserted with an exactfit into the recesses 14 of the holding element 13 and are separatedfrom one another by the webs 15. The test strip 18 is divided into asection 18 a, in which the test results can be read off, and a section18 b, on which the name of the analyte that is to be tested is marked.The section 18 a thus comprises the reagents which, by reacting with theanalytes to be tested, are responsible for indicating a test result. Thefact that the shape of the holding element 13 matches thecircumferential surface 16, extending in the example shown in FIG. 1peripherally over the entire inner circumference of the circumferentialsurface 16, means that the results can be read off very easily by sight.Moreover, the test strips 18 also have absorbent sections 19 via whichthe sample is taken up onto the test strip 18.

FIG. 1 also shows the sampling element 20. The latter comprises, at itsend to be inserted into the container 12, a sampler 22 with which, forexample, a sample of saliva can be taken from the mouth or throat. Thesampler 22 has a structure similar to cotton wool or sponge or is madeof a material that is able to absorb and store liquid. An elongate,rod-shaped section 23 connects the sampler 22 to the end section 24which, in the embodiment shown in FIG. 1, also comprises the grip 25 andthe closure means 26. The closure means 26 shown in FIG. 1 is a rotaryclosure means, that is to say a thread which is provided on the endsection and which, when the sampler 22 is inserted into the container12, engages with the mating thread 17 of the container 12.

The elements of the embodiment of the device according to the inventionshown in FIG. 1 are shown in the assembled state in FIG. 2a . It will beseen from FIG. 2 that the holding element 13 is inserted into thecontainer 12 such that the absorbent sections 19 of the test strips 18located in the holding element 13 are in contact with the base 15 of thecontainer 12. The sampling element 20 is also introduced into thecontainer 12 in such a way that the sampler 22 is inserted into thecontainer 12, and the closure means 26 engages with the mating thread 17of the container 12 in order to close the container 12.

FIG. 2b shows the same embodiment as in FIG. 2a , with the additionalfeature of a partial covering element 27 of the test strips 18. Thiscovering element 27 is applied, for example by adhesive bonding, to theouter surface of the container 12, specifically below the area 18 a,that is to say the area where the test results are indicated. Thecovering element 27 can, for example, carry instructions on how the testresults are to be evaluated, for example to the effect that, if a bandappears in the area 18 a of the test strip 18, the subject has testedpositive to a specific analyte (“pos”), or, if two bands appear in thearea 18 a, the subject is negative (“neg”) with respect to the analyte,and, if no band can be seen in the area 18 a, the test is invalid(“invalid”).

At the lower edge adjacent to the base 15, the circumferential surface16 of the container 12 can have a section 28 not covered by the coveringelement 27. This uncovered section 28 offers the possibility, forexample, of checking whether the liquid sample to be tested is presentin a sufficient quantity.

As has already been explained above, the holding element 13 can bedarker compared to the colour of the test strips 18, which makes thetest result easier to read off in the area 18 a, since the darkercolouring makes the contrast to the test strip greater than would be thecase with a brighter coloured holding element 13.

It will be appreciated that the whole container 12 can also be providedon its outer surface with a covering element and that in the area 18 a,i.e., where the test result is read off, there is an area in which thecovering element can be detached from the container such that the testresult and the area 18 a of the test strips can be seen from theoutside. The covering element can, for example, be adhesively bonded tothe outer surface of the container, the adhesive selected for the areathat is to be detached, to allow the test results to be read off, beinga more easily releasable adhesive than the one selected for the areasthat remain on the surface of the container.

FIG. 3 shows an enlarged view of the internal design of the base 15 ofthe container 12, the side wall of the container 12 having been cut awayto show the design of the base. It will be seen from FIG. 3 that thebase 15 has an elevation 30 in the form of an opened hemisphere, thelatter being arranged centrally on the base 15, with its curvaturepointing in the direction of the other end of the container 12. Theelevation 30 also comprises ridge-shaped elements 32 which, startingfrom the highest point of the elevation 30, are routed down the sidesthereof. The base 15 further comprises a depression or sample-collectingchannel 34 which is formed all round the edge to the circumferentialsurface and which collects the sample running down from the elevation 30and guided from the latter by the ridge-shaped elements 32. Theabsorbent sections 19 of the test strips 18 are received in thisdepression or sample-collecting channel 34, such that the sample locatedin the sample-collecting channel 34 can be taken up by the absorbentsections 19 into the test strips 18 by capillary forces, and the testfor determining the analyte or analytes can proceed on the one or moretest strips 18.

FIG. 4 shows a view in which the end of the sampling element 20comprising the sampler 22 is pressed onto the elevation 30 of the base15 of the container 12. The sample that has been taken up by the sampler22 and stored therein is thus squeezed out on the elevation 30 and runsdown the side of the latter into the sample-collecting channel 34. Theflow of the sample down from the elevation is additionally promoted bythe ridge-shaped elements 32 provided on the elevation 30, and theseelements 32 aid the uniform distribution of the sample in thecircumferential sample-collecting channel 34.

It will also be seen from FIG. 4 that the test strip 18 introduced intothe holding element 13 protrudes with its absorbent end 19 into thesample-collecting channel 34.

FIG. 5 shows in detail an embodiment of the end of the sampling element20 that comprises the grip 25 and/or the closure means 26. A B-samplecontainer 36 is provided centrally in the head of the sampling element20 and has a closure cap 38 that is to be firmly closed and that cannotbe opened again without this leaving a sign that it has been opened. Theclosure cap 38 has closure lamellae 39 extending around its side, and aself-sealing, pierceable sampling element 40 via which, for example,material for the B-sample can be removed using a syringe or cannula, asis shown schematically by the partially depicted syringe tip 42.

FIG. 6, finally, shows an enlarged view of the end of the samplingelement 20 comprising the closure means 26. The outermost end sectionforms a kind of grip 25, and the closure means 26 are designed in theform of a thread, which engages in a mating thread 17 provided on thecontainer 12. The mating threaded piece designated by 44 in FIG. 6 has acatch 46 which, when actuated, secures the mating thread 17. The catch46 can be made particularly noticeable by a corresponding marking or acorresponding indicator on the outer container, in order to indicate thepossibility of monitoring.

FIG. 7 shows a detailed view of a further embodiment of a samplingelement 44 of the device 10 according to the invention. The samplingelement 44 likewise has a sampler 51, a rod-shaped section 52 and a grip53. The rod-shaped section 52 also has a U-shaped recess 54—seen incross section—in which an indicator strip 46 for indicating the presenceof an amount of liquid sample sufficient for carrying out the assay isinserted. The indicator strip 46 protrudes with one of its ends 47 intothe sampler 51, making it possible for liquid sample that is taken up bythe sampler 51 to get into the indicator strip 46 of an absorbentmaterial. The liquid sample then migrates through the indicator strip 46as far as a specific zone 48 of the indicator strip 46 that lies at aspecific distance away from the sampler 51 in the rod-shaped section 52of the sampling element 44, and by means of which zone 48 it can beestablished that a sufficient amount of liquid sample is present in thesampler 51. This zone 48 may be provided with specific indicating meansby which it can be established, for example by means of a colourreaction, when the liquid sample enters the zone 48 that there issufficient sample to be able to carry out the assay.

In a further embodiment, it may be provided that the rod-shaped section52 of the sampling element 44 has a marking, for example at the level ofthe zone 48, which indicates the minimum travelling distance of theliquid sample on/through the indicator strip. The marking may be, forexample, a line or a notch in the rod-shaped section 52.

A further embodiment of the sampling element 60 is shown in FIGS. 8A-8B,FIG. 8A showing a longitudinal section through the sampling element 60,and FIG. 8B showing an exploded representation of the individual partsor sections of the sampling element 60. In the embodiment shown in FIGS.8A and 8B, said sampling element likewise has a sampler 61, as well asan elongate, rod-shaped section 62 and an end section 64, whichcomprises a grip 63 and closure means 65. The elongate, rod-shapedsection 61, and the end section 64 including the grip 63 and the closuremeans 65, are formed in one piece in the embodiment shown in FIGS. 8Aand 8B, in the form of a hollow rod 67 with a holding grip, which can beseen in particular in FIG. 8B. The sampler 61, a sponge-like element, isfastened to the end of the rod 67 that is to be inserted into thecontainer 12. An insertion element 68, which has a U-shaped recess69—seen in cross section—into which an indicator strip 66 can beinserted or placed, can be inserted into the rod 67. The rod 67 is inthis case produced from a transparent material, so that, after insertionof the insertion element 68 and the indicator strip 66 lying thereininto the hollow rod 67, it can be read off from the indicator stripwhether and when sufficient liquid sample has been taken up by means ofthe sampler 61.

A further embodiment of the device 70 according to the invention orparts thereof is shown in FIGS. 9A-9D with a container 72 and a holdingelement 73 arranged therein (FIG. 9A), which is also shown separately inFIG. 9B. As can be seen from FIGS. 9A and 9B, the holding element 73 hasa hollow angular-cylindrical shape, which is adapted to an innercircumferential surface 73.2 of the container 72, so that the holdingelement 73 can be inserted into the container 72 such that it fits. Thebase 75 of the device 70 is of a substantially rectangular design,corresponding to the angular-cylindrical shape of the circumferentialsurface 76. The holding element 73 has recesses 74 a and webs 74 b lyingbetween the recesses 74 a, both being delimited in a top section of theholding element 73 that is facing the open end of the container 72, andformed continuously as far as the end that in the inserted state isfacing the base 75 of the container 72. Test strips, which are not shownin FIGS. 9A-9D for reasons of clarity, may be inserted in the recesses74 a. In the inserted state, the lower end 77 of the holding element 73facing the base 75 of the container 72 ends at a specific distance fromthe base 75, so that the test strips present in the recesses 74 aprotrude with an absorbent section out of the holding element 73 and therecesses 74 a such that that they come into contact with the liquidsample that is preferably present between the base 75 at the lower end77 of the holding element 73, or are immersed in the sample.

The end 77 of the holding element also has centrally a holding elementopening 76 (see FIG. 10), which is dimensioned such that the samplingelement 80 can be guided with its sampler 82 through the holding elementopening 76 to the elevation (not shown in FIG. 9) present on the base 75and squeezed out on it. The holding element opening 76 is preferablysubstantially round or adapted for receiving and leading through thelower end 94 of the insertion element 90.

Shown in FIG. 9C is an embodiment of the sampling element 80 which canbe used in the case of the embodiment of the device 70 shown in FIG. 9and which corresponds substantially to the embodiment of the samplingelement shown in FIG. 8A and FIG. 8B. Accordingly, the sampling element80 has a sampler 82, an absorbent, sponge-like element by means of whichthe sample is taken up, as well as a rod-shaped section 83, and an endsection 84, which in turn has a grip 85 and closure means 86. In theembodiment shown in FIG. 9C, the closure means are a peripheral sealingring which interacts with an opening 92 in an insertion element 90 thatis represented in FIG. 9D when the sampling element 80 is inserted intothe opening 92 in the insertion element 90. The sealing ring engages inthe opening 92 in a sealing manner, so that slipping of the samplingelement 80 out of the insertion element 90 is avoided.

The insertion element 90 shown in more detail in FIG. 9D has asubstantially hollow cylindrical shape, with an opening 92 at the end bywhich the sampling element 80 is inserted, and with an open end 94, fromwhich the sampler 82 is at least partially led out in the direction ofthe base 75 of the container 72 and, as a result, can be pressed onto anelevation (not shown in FIG. 9) provided on the base 75 of the container72 and squeezed out.

FIG. 10 shows a cross section of the assembled device 70 from FIG. 9,i.e., the device 70 in which the sampling element 80 has been inserted,or is in the process of being inserted, together with the insertionelement 90 into the container 72 in which the holding element 73 is alsoalready arranged. In FIG. 10 it can be seen that the base 75 of thecontainer 72 is provided with an elevation 79 onto which the sampler 82can be compressed. In the region 96 of the sampling element 80, furthermeans may be provided, interacting with fixing means, for example athread inside or on the inner side of the container or the holdingelement, in order to bring about fixing of the sampling element. Theelevation 79 represented in FIG. 10 may likewise have ridge-shaped ribs,which however are not represented in FIG. 10 for better clarity.

To assemble the device 70, first the holding element 73 is inserted intothe container 72. Access to the elevation 79 on the base 75 of thecontainer 72 is ensured by the holding element opening 76 provided inthe lower end of the holding element. This can be followed by insertingthe insertion element 90 which, as can be seen in FIG. 9D, has twolateral flanges or a peripheral edge which comes to lie on the upperedge of the container 78 (see FIG. 9A) and thereby limits the insertionof the insertion element 90 into the container 72. The insertion element90, which is of a substantially cylindrical design, has at the lowerend, facing the base 75 of the container 72, the open end 94, throughwhich access to the elevation 79 on the base 75 of the container 72 isensured for the sampler 82 that is to be squeezed out on it. Insertionof the sampling element 80 has the effect that the end section 84 sealsoff the opening 92 in the insertion element 90 in a sealing manner bymeans of the sealing ring 86 and thereby closes the device 70. At thesame time, the sampler 82 is compressed on the elevation 79, so that thesample previously taken up in it, in particular saliva sample, issqueezed out on the elevation 79.

A plan view of the base 75 of the container 72 is shown in FIG. 11, theperipheral circumferential surface 76 not being represented for reasonsof clarity.

As can be seen in FIG. 11, centrally on the base 75 there is ahemispherical elevation 79, onto which the sampler 82 can be squeezedout. Also on the base there are lateral elevations 81 a and 81 b, whichare formed at a distance from the elevation 79 and adjoining the shortside walls of the substantially rectangular base 75. By the elevations81 a and 81 b, the sample or saliva running off over the elevation 79 isrespectively guided laterally to the long side edges of the base 75, asshown by the arrows 98 a and 98 b. The absorbent sections of the teststrips 18 protrude into these side edges of the base 75, so that thesample can reach the test strips via these absorbent sections and thetest can thereby be started.

It will be appreciated that the container is made of a transparentmaterial, preferably plastic, in order to be able to read off the testresult on the test strips 18 visually or mechanically with a scanner.

It will be appreciated that the device is not limited to the embodimentsdescribed above. In particular, the number of test strips can vary asrequired, and the structure of the container is also variable and doesnot necessarily have to be in the form of a container with a circularcross section. Accordingly, the configuration of the holding element canalso differ from the one described in the embodiments. Instead of thesemicircular, curved shape illustrated here, it is possible inparticular for the holding element to have a tubular shape and thus bearabout the full circumference of the circle on the inner face of thecircumferential surface. It is also conceivable for the lid of thecontainer to be replaced by another closure element, in particular by aclosable flap. The cover element too is not limited to a three-partstructure, and instead it can also be in the form of a multi-part orjust one-part or two-part cover element.

Irrespective of the particular embodiment, the device according to theinvention can be used for any type of test for a drug or for multipledrugs. The sample of fluid can be tested at one and the same time forseveral drugs, including amphetamines (AMP 1000), barbiturates (BAR300), benzodiazepines (BZD 300), cocaine (COC 300), marihuana (THC 50),methadone (MTD 300), methamphetamine (MET 1000),methylenedioxy-methamphetamine (MDMA 500), morphine (MOR 300), opiates(OPI 2000), oxycodone (OXY 100), phencyclidine (PCP 25), propoxyphene(PPX 300), tricyclic antidepressants (TCA 1000), buprenorphine (BUP 10),cotinine (COT 200), EDDP (EDDP 100) and fentanyl (FYL 10). An alcoholtest and at least one adulteration test can be integrated into thedevice.

The main advantages of the invention are the simple handling of thedevice according to the invention and the possibility of being able tosend the sample to a certified laboratory without exchanging anyelements and without removing the test strips. This permits quick,hygienic and more reliable implementation of the test and does notrequire any special knowledge on the part of the person conducting thetest.

What is claimed is:
 1. A device for determining the presence of one ormore analytes in a sample of human body fluid, comprising: a containerfor receiving a sample of body fluid, with an interior that is delimitedby a base and by a circumferential surface having an inner face; atleast one test strip including an absorbent section and reagents fordetermining a presence of one or more analytes in the sample of bodyfluid; a holding element for receiving and holding the one or more teststrips, said holding element having a shape corresponding to at least aportion of the circumferential surface of the container, the holdingelement positioned at the at least a portion of the circumferentialsurface and bearing upon an inner face of the circumferential surfaceand holding the at least one test strip; an elongate sampling elementincluding an insertion element and an absorbent sampler at a first endof the insertion element, the absorbent sampler being insertable intothe container for transfer of the sample of body fluid into thecontainer, wherein at least one of the insertion element and theabsorbent sampler includes an indicator for indication of the presenceof the liquid sample sufficient for determining the presence one or moreanalytes in the sample.
 2. The device of claim 1, wherein the test stripis configured to determine an amount of the one or more analytes.
 3. Thedevice of claim 1, wherein the indicator comprises a strip of anabsorbent material present in the sampling element.
 4. The device ofclaim 3, wherein the indicator is configured as an indicator strip. 5.The device according to claim 3, wherein the sampling element has amarking for indicating minimum travelling distance of the sample of bodyfluid through the indicator strip.
 6. The device of claim 1, wherein theholding element is shaped with pretensioning and clamped into thecontainer.
 7. The device of claim 1, wherein the holding element is atleast partially bonded to the circumferential surface on the inside ofat least one of the container and the base.
 8. The device of claim 1wherein the holding element extends entirely around the circumferentialsurface.
 9. The device of claim 1 wherein the container is transparentand has a planar surface, and the holding element has a portioncorresponding to the planar surface and has a plurality of verticalrecesses each with a plurality of test strips therein, and the teststrips are positioned and visible through the holding element at theplanar surface.
 10. A device for determining the presence of one or moreanalytes in a sample of human body fluid, comprising: a container forreceiving a sample of body fluid, with an interior that is delimited bya base and by an inner circumferential surface, the container having apair of opposing planar sides; a plurality of test strips, eachincluding an absorbent section and reagents for determining a presenceof one or more analytes in the sample of body fluid; a holding elementfor receiving and holding the plurality of test strips, said holdingelement having a shape corresponding to the inner circumferentialsurface of the container, the holding element having a pair of sideswith vertical recesses therein, each side positioned at one of theopposing planar sides, the plurality of recesses receiving and holdingthe plurality of test strips; and an elongate sampling element includingan insertion element and an absorbent sampler at a first end of theinsertion element, the absorbent sampler being insertable into thecontainer for transfer of the sample of body fluid into the container;wherein the insertion element includes an indicator for indication ofthe presence of the liquid sample sufficient for determining thepresence of analytes in the sample.
 11. The device of claim 10 fordetermining the presence of one or more analytes in a sample of humanbody fluid, wherein the holding element is a single unitary piece thatextends entirely around the inner circumferential surface.